Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema

NCT01309451

Diabetic Macular Edema

COMPLETED PHASE4

Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion

NCT01295112

Non-Ischemic Central Retinal Vein Occlusion

COMPLETED PHASE2/PHASE3

Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema

NCT01298076

Diabetic Retinopathy Macular Edema

COMPLETED PHASE2

Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery

NCT04067856

Diabetic Macular Edema Cataract

WITHDRAWN NA

Central Retinal Vein Occlusion (CRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.

NCT04601701

Central Retinal Vein Occlusion

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Edema Central Retinal Vein Occlusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.

Group Type EXPERIMENTAL

Ozurdex

Intervention Type DRUG

Ozurdex, 0.7mg dexamethasone

Avastin

Intervention Type DRUG

Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Group 2

Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Group Type ACTIVE_COMPARATOR

Avastin

Intervention Type DRUG

Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ozurdex

Ozurdex, 0.7mg dexamethasone

Intervention Type DRUG

Avastin

Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dexamethasone implant Avastin, bevacizumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Presence of central retinal vein occlusion (CRVO)
* Age 18 years or older
* ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800
* OCT Central foveal thickness \>250 microns
* Negative pregnancy test for women of childbearing potential
* Ability to provide written informed consent
* Capable of complying with study protocol

Exclusion Criteria

* History of glaucoma in the study eye with intraocular pressure \>21mmHg on more than one topical medication. Combination drugs are considered more than one medication
* History of steroid-related glaucoma (steroid response)
* Previous intraocular injection of steroid medication within 90 days
* Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days
* Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician
* Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days
* Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician
* Dense cataract that precludes clinical examination and retinal imaging of the retina
* History of allergy to dexamethasone, bevacizumab, betadine
* Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician
* Unwilling or unable to follow or comply with all study related procedures
* Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No